Post-MarketSurveillance(PMS)inMedicalDevices:USA&EU

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Post-MarketSurveillance(PMS)inMedicalDevices:USA&EU

May72025

Asaregulatoryleader,yourresponsibilitydoesn’tendwithmarketapproval,itbeginsthereThis sentimentechoesacrossboardroomsandregulatorystrategymeetingsaspost-marketsurveillance (PMS)becomesacriticalpillaroflifecyclemanagementinmedicaldevicesInthetimeswherereal-world performance,patientsafety,andglobalcomplianceareunderthespotlight,PMSisastrategic advantage

Accordingtoglobalregulatoryexperts,theabilitytopredict,monitor,andactonpost-marketdataisfast becomingabenchmarkforexcellenceinmedicaldeviceoversightWhiletheUSFDAandtheEuropean Union(EU)bothprioritizePMStheirframeworksreflecttwodistinctphilosophies:theFDAsreactiveyet data-drivenmodelversustheEU’sproactivelifecycle-integratedsystemunderMDR2017/745

Forcompanieswithglobalaspirations,understandingthesenuancesin2025isessentialtosafeguarding brandreputationachievecomplianceandmaintainmarketaccess

UnderstandingPost-Market SurveillancePMS

Post-MarketSurveillancereferstotheongoingandsystematiccollection,analysis,andinterpretationof datarelatedtoamedicaldeviceafteritisplacedonthemarketIthelpsinidentifyingrisksevaluating benefit–riskratios,andsupportingregulatoryactionssuchassafetycommunications,recalls,orlabeling updatesPMSisalsoafundamentalinputintothemanufacturersCorrectiveandPreventiveAction (CAPA)andQualityManagementSystem(QMS)processes

USAPMSRequirementsUnder FDA Regulations

IntheUnitedStates,PMSactivitiesareprimarilygovernedby21CFRPart803,whichcoversMedicalDevice Reporting(MDR)

KeyStakeholdersandResponsibilities

Manufacturers&Importers:Mustreportdevice-relateddeathsseriousinjuries,andcertain malfunctions

UserFacilities(eg,hospitals):RequiredtoreportdeathstotheFDAandseriousinjuriesto manufacturers(ortotheFDAifthemanufacturerisunknown)

Distributors:Notrequiredtoreportroutinelybutmustmaintainrecordsofcomplaintsandprovide themuponrequest

TimelinesforMDRSubmission

30calendardaysforstandardadverseeventreports

5workdaysforeventsrequiringremedialactiontopreventanunreasonableriskofsubstantial harm

10workdaysforuserfacilitiestoreporttotheFDAormanufacturersdependingonthenatureofthe event

ElectronicMedicalDeviceReporting(eMDR)

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VITALIC®-RIMSSoftware OnePlatform|Multiple Solutions BookForDemo

Since2015allMDRsubmissionsmustbemadeelectronicallyviatheFDAsElectronicSubmissions

Gateway(ESG)Manufacturerscanuse

eSubmittersoftware(forMedWatch3500AXMLfiles),or

AS2GatewayusingHL7ICSR-compliantXMLformats

MAUDEDatabase

SubmittedMDRsaremadepubliclyavailablethroughtheManufacturerandUserFacilityDevice Experience(MAUDE)databaseenhancingtransparencyandenablingstakeholderstomonitorsafety profiles

RecentDevelopments(2023–2025)

WhilenomajoramendmentstoPart803haveoccurred,theFDAhasreleased TechnicalupdatestotheeMDRvalidationprocess, Guidanceencouragingintegrationofreal-worldevidence(RWE)and EnhancementsalignedwithIMDRFharmonizationgoals

ManufacturersareadvisedtotracktheCDRHeMDRenhancementsscheduleforthelatestupdates

EUPMSUnder RegulationEU2017/745 MDR

IntheEUPMSisgovernedbyChapterVIIandAnnexIIIofMedicalDeviceRegulation(MDR)2017/745The approachisproactiveandlifecycle-based,tightlyintegratedintoamanufacturer’sQMS

PMSPlanandSystem(Articles83–84)

ManufacturersmustestablishandmaintainaPMSsystem,documentedthroughaPMSPlanthatoutlines: Datasources(eg,complaints,literature,userfeedback)

Analyticalmethodologies,

Riskassessmentcriteria,and

Correctiveactionprotocols

PMSReportingDocumentation

PMSReport:RequiredforClassIdevicesandkeptinternally.

PSUR(PeriodicSafetyUpdateReport):

MandatoryforClassIIa,IIb,andIIIdevices

SubmittedannuallyforClassIIIandClassIIbimplantables;everytwoyearsforClassIIaandother IIbdevices

ReviewedbyNotifiedBodiesforClassIIbandIII

VigilanceReporting(Article87)

Seriousincidentsandfieldsafetycorrectiveactions(FSCAs)mustbereported

Timelines

2daysforseriouspublichealththreats

10daysfordeathorseriousdeterioration

15daysforallotherseriousincidents

TrendReporting(Article88)

Uniquely,EUMDRmandatesreportingofstatisticallysignificantincreasesinnon-seriousincidentsor sideeffectsthatmayimpactthedevice’sbenefit–riskprofileManufacturersmust DefinetrendthresholdsinthePMSPlan

Regularlyanalyzedataand

Reportfindingsifthresholdsareexceeded

EUDAMEDPlatform

TheEuropeanDatabaseonMedicalDevices(EUDAMED)isacentralizedITsystemfor: Deviceregistration

Clinicalinvestigations, Vigilancereporting

PMSactivities

Asof2025severalmodules(vigilancemarketsurveillanceandclinicalinvestigations)areoperational butfullmandatoryuseisstillpendingaEuropeanCommissionnotice

NotifiedBodiesRole

ForClassIIbandIIIdevices,NotifiedBodiesreviewPSURsanduploadevaluationsintoEUDAMEDThisadds alayerofexternaloversightabsentintheUSsystem

USA vs EUPMSA ComparativeSnapshot

Conclusion

Post-marketsurveillanceismorethanaregulatoryrequirement itisacornerstoneofensuringongoing patientsafety,effectiveriskmanagementandproductperformance

IntheUS theFDA’sapproachemphasizesreactiveadverseeventreportingthroughMDRand publictransparencyviaMAUDE

IntheEU,MDRhasintroducedacomprehensiveandproactivesystem,featuringperiodicreporting trendmonitoringandoversightbyNotifiedBodies

Manufacturersoperatinggloballymustinvestin:

RobustQMSandCAPAsystems, Integratedregulatoryintelligenceand Digitaltoolstohandlediversesubmissionformatsanddatabases(eg ESGEUDAMED)

As2025unfoldsandregulatorscontinuerefiningtheirPMSframeworks,stayinginformedagileand alignedwithreal-worldevidence-drivensafetystrategieswillbecriticaltosuccess

About DDReg

DDRegisattheforefrontofsupportingmedicaldevicemanufacturersinnavigatingcomplexregulatory landscapeslikePMSWithoveradecadeofexperienceinregulatorystrategy,DDRegpartnerswith companiestoensuretheynotonlycomplywithevolvingregulationsbutalsoleveragepost-marketdata toenhancesafety,streamlinereporting,andprotectpatientwell-beingOurexpertiseinbothUSFDAand EUregulationsallowsustoguideyouthroughtheintricaciesofPMS,offeringtailoredsolutionsthatdrive globalcomplianceandoperationalsuccess

Readmorefromushere:UnderstandingSoftwareasaMedicalDevice(SaMD)